510(k) Report

Devices descending from K150216

149 later devices reach Synergy Cranial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+1K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc.20193Class I
+1K163209Fiagon Navigation SystemFiagon GmbH20170—
+1K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.2016144Class I
+1K151156Fiagon Navigation SystemFiagon GmbH20161—
+2K252322SIros-X SystemGenesys Spine20250—
+2K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc.20222Class I
+2K170011StealthStation S8 Spine Software v1.0.0Medtronic Navigation2017126—
+2K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+2K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.201739Class I
+3K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+3K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+3K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+3K231976StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc.20231—
+3K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+3K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+3K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+3K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+3K211254ARAI Surgical Navigation SystemSurgalign Spine Technologies20221—
+3K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+3K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K192663Joimax Intracs SystemJoimax GmbH20201—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K201175StealthStation Cranial Software v1.3.0Medtronic Navigation, Inc.20208—
+3K201189Stealthstation S8 Spine Software v1.3.0Medtronic Navigation, Inc.2020151
+3K190929xvision Spine system (XVS)Augmedics, Ltd.201931—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+4K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+4K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc.20252—
+4K250477NextAR (TM) SpineMedacta International S.A.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K233725Spine Navigation SystemMedivis, Inc.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K230700RIWOtrack Navigation SystemFiagon GmbH20230—
+4K231611HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies20230—
+4K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+4K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K213034SpineAR SNAPSurgical Theater, Inc.20222—
+4K213989Cranial EM SystemBrainlab AG20221—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K220146VisARNovarad Corporation20220—
+4K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211188xvision Spine system (XVS)Augmedics, Ltd.202181
+4K202750Knee+Pixee Medical20218—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K200935Mazor XMazor Robotics, Ltd.202015—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.202411
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+5K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+5K220905xvision Spine SystemAugmedics, Ltd.20227—
+5K220104Knee+Pixee Medical20227—